Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03827564
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
• Actual Study Start Date: Jun 24, 2019
• Actual Primary Completion Date: Jun 8, 2020
• Actual Study Completion Date: Jun 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITN [TrueTear®] - Intranasal Application Intranasal application of the ITN. Single application at application visit.	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]; The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
Experimental: ITN [TrueTear®] - Extranasal Application Extranasal application of the ITN. Single application at application visit.	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]; The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.

Outcome Measures

Primary Outcome Measures

1. Difference in Ratio of Degranulated Goblet Cells. [Screening (Day -60 to Day -30) to Application Visit (Day 0)]

   Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

• Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study

• The participant should be literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding

• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas

• Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

• Corneal transplant in either or both eyes

• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

• Women who are pregnant, planning a pregnancy, or nursing throughout the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine - Department of Ophthalmology	Houston	Texas	United States	77030-3411

Sponsors and Collaborators

• Allergan

Investigators

• Principal Investigator: Stephen Pflugfelder, MD, Baylor College of Medicine, Department of Ophthalmology

Study Documents (Full-Text)

• Study Protocol - Mar 4, 2019

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03827564
• Other Study ID Numbers: 1919-802-019
• First Posted: Feb 1, 2019
• Last Update Posted: Aug 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Allergan: Dry Eye Disease
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

Participant Flow

Arm/Group Title	ITN [TrueTear®] - Intranasal Application	ITN [TrueTear®] - Extranasal Application
Arm/Group Description	Intranasal application of the ITN. Single application at application visit.	Extranasal application of the ITN. Single application at application visit.
Period Title: Overall Study
STARTED	9	5
COMPLETED	8	5
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	ITN [TrueTear®] - Intranasal Application	ITN [TrueTear®] - Extranasal Application	Total
Arm/Group Description	Intranasal application of the ITN. Single application at application visit.	Extranasal application of the ITN. Single application at application visit.	Total of all reporting groups
Overall Participants	9	5	14
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.2 (15.4)	46.8 (10.4)	52.2 (14.0)
Sex: Female, Male (Count of Participants)
Female	7 77.8%	3 60%	10 71.4%
Male	2 22.2%	2 40%	4 28.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 33.3%	1 20%	4 28.6%
Not Hispanic or Latino	6 66.7%	4 80%	10 71.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 11.1%	0 0%	1 7.1%
White	8 88.9%	5 100%	13 92.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Difference in Ratio of Degranulated Goblet Cells.
Description	Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Time Frame	Screening (Day -60 to Day -30) to Application Visit (Day 0)

Outcome Measure Data

Analysis Population Description

Of the 14 Randomized participants, 13 received a single application of the Intranasal Tear Neurostimulator (ITN)

Arm/Group Title	ITN [TrueTear®] - Intranasal Application	ITN [TrueTear®] - Extranasal Application
Arm/Group Description	Intranasal application of the ITN. Single application at application visit.	Extranasal application of the ITN. Single application at application visit.
Measure Participants	6	5
Mean (Standard Deviation) [Ratio]	0.007 (0.171)	0.124 (0.069)

Adverse Events

Time Frame	Adverse data was collected from participants at Screening (Day -60 to Day -30) to the Application Visit (Day 0), with a 30-day safety follow-up after the application. A period of 60 to 90 days in total.
Arm/Group Title	ITN [TrueTear®] - Intranasal Application		ITN [TrueTear®] - Extranasal Application
Arm/Group Description	Intranasal application of the ITN. Single application at application visit.		Extranasal application of the ITN. Single application at application visit.
All Cause Mortality
	ITN [TrueTear®] - Intranasal Application		ITN [TrueTear®] - Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)
Serious Adverse Events
	ITN [TrueTear®] - Intranasal Application		ITN [TrueTear®] - Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	ITN [TrueTear®] - Intranasal Application		ITN [TrueTear®] - Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)

Limitations/Caveats

This study was terminated early, resulting in a small number of patients analyzed. Only a descriptive statistical analysis will be performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Allergan as the sponsor has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between investigators and Allergan personnel. Authorship will be established prior to the writing of the manuscript. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.